This document discusses the importance of collaborations between universities and industry, especially for natural product research. It notes that universities have become the primary source of biopharma innovation and discovery. However, natural product research presents challenges such as long timelines, complex sourcing and production, and uncertain patent and regulatory frameworks. The document emphasizes that university collaborations are critical for the biopharma industry to overcome these challenges. It also discusses the role of intellectual property in facilitating innovation through licensing between academia and industry.

1. Making Natural Product Research
Work: The Importance of
Collaborations and IP
Mark Crowell
Executive Director, UVa Innovation
Associate Vice President for Research
IFPMA Technical Briefing – 5 February 2013
Geneva, Switzerland

2. Universities – the incubator for the
biopharma industry
 In 2006, US universities launched more than
550 startups, most in biopharma (2/3 of
biotech startups from academia)
 Vast majority of biologics on market today
developed with university input
 Top 20 biotech patenting entities dominated
by universities; all of “most cited” biotech
patents are from academia
2

3. Universities increasingly are primary
engine of discovery / innovation for bio
 Company pipelines drying up - since 1980, large
biopharma companies’ share of new FDA-
approved drugs has declined from ~75% to ~35%
 >40% of pharma execs want to partner with
academia or acquire biotechs to acquire
innovation pipeline – new models
 As biopharma and VC move downstream,
academia must address the risk and uncertainty of
translation
3

4. Lifecycle of a Product: Clinical
Development
4

5. Lifecycle of a Product: Clinical
Development
5

6. Key opportunities – and challenges – with
natural products
 Historical success
 Natural products libraries offer
diversity of leads not typically
found in synthetic chemical
libraries; BUT…
 Longer discovery timelines
 Complexities in sourcing and in
large scale production
 Other challenges in patenting/
regulatory schemes
 Uncertain disclosure
requirements heighten risk
6

7. University collaborations critical in
biopharma – especially natural products
 Screening/drug development capabilities previously
only in industry; today in academia
 Funding agencies / foundations emphasizing
translation; new NIH entity and programs
 New models of collaborations and partnerships
(companies, NFPs, others)
 Universities engaging aggressively in entrepreneurial /
economic development activities
 Universities well-positioned as “honest broker” in the
natural products space
 Academic culture change – best talent wants to
collaborate with industry – and change society
7

8. Role of IP in innovation “ecosystem”
between academia and industry
 US Law (Bayh-Dole Act) and similar laws
elsewhere gave universities title to patents
 Goal - societal and economic benefit
 National policy frameworks allow universities
to grant licenses, including exclusive licenses
 Bayh-Dole provides flexibility for universities in
financial terms of licensing
 Patents (and Data Exclusivity) – provide
essential exclusivity needed to attract investors
8

9. Critical components for universities
within innovation ecosystem
 Strong, certain, predictable IP system in which
university can be strong player/partner – high-
risk of biotech requires robust IP system
 Strong science (where it all starts)
 Capital
 Talent
 Founders / Employees
 Investors / Advisors
 Industry partners/collaborators
9

10. Thank you for your attention
Mark Crowell
Chair, BIO Technology Transfer
Committee
Executive Director, UVa Innovation
Associate Vice President for Research
University of Virginia
mcrowell@virginia.edu
10